FDA Inspection
Cosmaceutical Research Lab Inc.Cosmaceutical Research Lab Inc. – FDA Inspection, Sep 23, 2016
Record Details
This FDA Inspection record concerns Cosmaceutical Research Lab Inc., with an inspection on September 23, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 23, 2016
- Product Type
- Drugs
View Company Profile
ID · 97044736-ffb3-4a8c-9736-6f007983ac90
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986769
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.182Written records kept in individual logs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cosmaceutical Research Lab Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 12, 2024 | OAI | Office of Inspections and Investigations | Drug Quality Assurance |
| June 10, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 15, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Cosmaceutical Research Lab Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.